- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00125944
Study to Evaluate the Safety of a Bivalent Vaccine of New 6:2 Influenza Virus Reassortants in Healthy Adults
May 8, 2007 updated by: MedImmune LLC
A Prospective, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety of a Bivalent Vaccine of New 6:2 Influenza Virus Reassortants in Healthy Adults
The objective is to assess the safety of bivalent vaccine of two new 6:2 influenza virus reassortants in healthy adults prior to the release of the trivalent vaccine (FluMist) containing them.
Study Overview
Study Type
Interventional
Enrollment
300
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
San Diego, California, United States, 92123
- Radiant Research, San Diego
-
-
Florida
-
Daytona Beach, Florida, United States, 32114
- Radiant Research, Daytona Beach
-
-
Oregon
-
Portland, Oregon, United States, 97239
- Radiant Research
-
-
Texas
-
San Antonio, Texas, United States, 78229
- Healthcare Discoveries, Inc.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 49 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Males or females, 18 to 49 years of age (not yet reached their 50th birthday) at the time of study vaccination
- Healthy by medical history and health assessment
- Sexually active females, unless surgically sterile or at least 1 year post-menopausal, must have used an effective method of avoiding pregnancy (including oral, implanted, injectable, or transdermal contraceptives, intrauterine device [IUD], female condom, diaphragm with spermicide, cervical cap, abstinence, use of a condom by the sexual partner or sterile sexual partner) for at least 30 days prior to study vaccination, and must agree to continue using such precautions for at least 90 days after study vaccination; the volunteer must also have a negative serum or urine pregnancy test within 14 days prior to study vaccination (if screening and study vaccination do not occur on the same day) and on the day of study vaccination prior to randomization
- Sexually active males, unless surgically sterile, must use an effective method of birth control (condom or abstinence) and must agree to continue using such precautions for at least 30 days after study vaccination
- Available by telephone
- Written informed consent (and Health Insurance Portability and Accountability Act [HIPAA] authorization if applicable) obtained from the participant
- Ability to understand and comply with the requirements of the protocol, as judged by the investigator
- Ability to complete follow-up period of 180 days after study vaccination, as required by the protocol
Exclusion Criteria:
- History of hypersensitivity of any component of the vaccine, including egg or egg protein
- History of hypersensitivity to gentamicin
- Any condition for which the inactivated influenza vaccine is indicated, including chronic disorders of the pulmonary or cardiovascular systems (e.g., asthma); chronic metabolic diseases (e.g., diabetes mellitus); renal dysfunction; or hemoglobinopathies that required regular medical follow-up or hospitalization during the preceding year.
- Acute febrile (>100.0°F oral or equivalent) and/or clinically significant respiratory illness (e.g., cough or sore throat) within the 14 days prior to randomization
- Any known immunosuppressive condition or immune deficiency disease, including HIV infection, or ongoing immunosuppressive therapy
- History of Guillain-Barré syndrome
- Household contact who is immunocompromised (participant should also avoid close contact with immunocompromised individuals for at least 21 days post study vaccination)
- Receipt of any investigational agent within 30 days prior to enrollment, or expected receipt through 180 days after study vaccination (use of licensed agents for indications not listed in the package insert is permitted)
- Chronic or regular use of anti-pyretic or analgesic medication on a daily or every other day basis.
Note: A daily dose of 81 mg of aspirin is not considered a contraindication to enrollment. Discontinuation of prophylactic use of anti-pyretic or analgesic medications at the time of enrollment and for 14 days following vaccination is not considered a contraindication to enrollment.
- Administration of intranasal medications within 14 days prior to randomization, or expected receipt through 14 days after study vaccination
- Nursing mother
- Employee of the research center, any individual involved with the conduct of the study, or any family member of such individuals
- Any condition that, in the opinion of the investigator, would interfere with evaluation of the vaccine or interpretation of study results
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
The primary endpoint of this study is fever (Study Days 0-7), defined as oral temperature of at least ³101°F.
|
Secondary Outcome Measures
Outcome Measure |
---|
Reported Reactogenocity Events (REs) and Adverse Events (AEs) that occur within 7 days after vaccination and that occur within 14 days after vaccination. SAEs and SNMCs that occur within 28 days after vaccination and within 180 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Robert Walker, MD, MedImmune LLC
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2005
Study Completion
January 1, 2006
Study Registration Dates
First Submitted
August 1, 2005
First Submitted That Met QC Criteria
August 1, 2005
First Posted (Estimate)
August 2, 2005
Study Record Updates
Last Update Posted (Estimate)
May 9, 2007
Last Update Submitted That Met QC Criteria
May 8, 2007
Last Verified
May 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MI-CP125
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Healthy
-
Prevent Age Resort "Pervaya Liniya"RecruitingHealthy Aging | Healthy Diet | Healthy LifestyleRussian Federation
-
Yale UniversityNot yet recruitingHealth-related Benefits of Introducing Table Olives Into the Diet of Young Adults: Olives For HealthHealthy Diet | Healthy Lifestyle | Healthy Nutrition | CholesterolUnited States
-
Maastricht University Medical CenterCompletedHealthy Volunteers | Healthy Subjects | Healthy AdultsNetherlands
-
Hasselt UniversityRecruitingHealthy | Healthy AgingBelgium
-
Galera Therapeutics, Inc.Syneos HealthCompleted
-
Galera Therapeutics, Inc.Syneos HealthCompletedHealthy | Healthy VolunteersAustralia
-
University of PennsylvaniaActive, not recruitingHealthy | Healthy AgingUnited States
-
Chalmers University of TechnologyGöteborg UniversityCompletedHealthy | Nutrition, HealthySweden
-
University of ManitobaNot yet recruitingHealthy | Healthy Diet
Clinical Trials on FluMist
-
MedImmune LLCAstraZenecaCompletedHealthy | InfluenzaUnited States
-
MedImmune LLCCompletedHealthy or Stable Underlying Chronic Medical ConditionUnited States
-
MedImmune LLCCompleted
-
MedImmune LLCCompletedHealthy or Stable Chronic IllnessUnited States
-
MedImmune LLCCompleted
-
National Institute of Allergy and Infectious Diseases...Completed
-
Stanford UniversityNational Institute of Allergy and Infectious Diseases (NIAID); National Institutes...WithdrawnInfluenzaUnited States
-
University of North Carolina, Chapel HillMedImmune LLC; University of North CarolinaCompleted
-
MedImmune LLCCompletedHealthyUnited States
-
MedImmune LLCCompleted